Comparison Of The Efficacy And Safety Of Sedation Protocols With The Use Of Dexmedetomidine-Remifentanil And Propofol-Remifentanil During Percutaneous Closure Of Atrial Septal Defects

Objectives:The study was aimed to compare the efficacy and safety of different sedation regimens with the use of dexmedetomidine-remifentanil and propofol-remifentanil for percutaneous closure of atrial septal defects（ASD）.Method:A total of 60 ASD patients scheduled for percutaneous closure under transthoracic echocardiography guidance were randomly allocated into a dexmedetomidine-remifentanil（D-R）group（n=30）and the propofol-remifentanil（P-R）group（n=30）for sedation.The sedation depth was assessed with the Observer’s Assessment of Alertness/Sedation（OAA/S）scale and bispectral index（BIS）.Intraoperative sedation levels were targeted to achieve an OAA/S score<3 and a BIS of60-80.The infusion rate of remifentanil was set at 4.0μg·kg^-1·h^-1 in both groups.The initial infusion of dexmedetomidine was set at 6.0μg·kg^-1·h^-1 for 10 minutes as the loading dose in the D-R group,followed by a maintenance infusion beginning at a rate of 1μg·kg^-1·h^-1.The initial infusion of propofol was set at 6.0 mg·kg^-1·h^-1 for 10 minutes in the P-R group,followed by continuous infusion beginning at a rate of 2mg·kg^-1·h^-1.The maintenance infusion rate of all drugs could be adjusted to maintain proper target sedation depth.If patients needed deeper sedation immediately or complained of pain,a bolus of 10-30 mg propofol or of 5-10μg remifentanil was administered as a rescue sedation therapy.The efficacy of sedation protocols was assessed on induction time,recovery time,pain score,infusion rate of remifentanil,number of patients who need additional sedatives and with apparent body movement,satisfaction of the surgeon and patient.The incidence of hemodynamic and respiratory adverse events,and the outcome of arterial blood gas analysis were all compared to evaluate the safety of sedation protocols.Results:1.In two groups,the baseline patients characteristics were no significant differences and were comparable（P>0.05）.2.In terms of sedation efficacy:（1）All ASD patients successfully completed procedure without body movement leading to interruption of procedure.The number of patients requiring sedative therapy was not significantly different between the two groups（P>0.05）.（2）The induction time was shorter in the P-R group than in the D-R group（P<0.001）.（3）There were not significant differences of recovery time,remifentanil infusion rate,pain score in the two groups（P>0.05）.（4）The patient satisfaction score were comparable（P>0.05）,whereas the surgeon satisfaction score was higher in P-R group than in D-R group（P<0.05）.3.In terms of sedation safety:（1）The incidence of respiratory adverse events were significantly less frequent in the D-R group compared with the P-R group（P<0.05）.（2）The incidence of hemodynamic adverse events was comparable between the two groups（P>0.05）.（3）The outcome of the arterial blood gas analysis:Pa CO₂ values were significantly higher and hypercapnia was more frequent,and p H and Pa O₂ values were lower in the P-R group than in the D-R group at the end of the procedure（P<0.05）.4.Operative complications:There were no significance of the surgery-related complications in both group（P>0.05）.Conclusions:In the term of efficacy,both sedation protocol have comparable efficacy for providing sufficient sedative and analgesic effects,however,the time to target sedation level was more rapid and the surgeon satisfaction score was higher in the propofol-remifentanil protocol than in the dexmedetomidine-remifentanil sedation protocol.In terms of sedation safety,considering that the hemodynamic stability was comparable,we concluded that dexmedetomidine-remifentanil protocol had superior airway security since it was associated with fewer hypercapnia and respiratory adverse events.In clinical,we can choose a sedation regimen tailored according to the risk assessment of patients.